NCT00555776

Brief Summary

The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 6, 2009

Status Verified

August 1, 2008

Enrollment Period

1.2 years

First QC Date

November 8, 2007

Last Update Submit

January 5, 2009

Conditions

Subjective Tinnitus

Keywords

tinnitusgabapentin

Outcome Measures

Primary Outcomes (1)

  • Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin.

    two months

Secondary Outcomes (1)

  • Relieve of complications of tinnitus, such as sleep difficulties.

    two months

Study Arms (2)

1

ACTIVE COMPARATOR

Randomly,half of the subjects are given Gabapentin.

Drug: Gabapentin

2

PLACEBO COMPARATOR

Randomly,half of the subjects receive placebo.

Drug: placebo

Interventions

GabapentinDRUG

Gabapentin, 600 mg bid for the first two weeks, increased to a maximum dose of 1800 mg per day during the next 6 weeks if necessary.

Also known as: Neurontine
1
placeboDRUG

placebo is given with the same definition as Gabapentin

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with subjective idiopathic tinnitus

You may not qualify if:

  • tinnitus with known underlying cause
  • pregnant women and patients younger than 18 or older than 75 years
  • patients with impaired renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT department of Mashhad Azad medical university

Mashhad, Khorasan Razavi, 91786 56553, Iran

Location

Related Publications (1)

  • Bakhshaee M, Ghasemi M, Azarpazhooh M, Khadivi E, Rezaei S, Shakeri M, Tale M. Gabapentin effectiveness on the sensation of subjective idiopathic tinnitus: a pilot study. Eur Arch Otorhinolaryngol. 2008 May;265(5):525-30. doi: 10.1007/s00405-007-0504-9. Epub 2007 Oct 25.

    PMID: 17960408RESULT

MeSH Terms

Conditions

Tinnitus

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Mahboobeh Adami Dehkordi, MD

    ENT department of Mashhad azad university of mashhad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

January 1, 2007

Primary Completion

April 1, 2008

Study Completion

October 1, 2008

Last Updated

January 6, 2009

Record last verified: 2008-08

Locations

IR(1)